NCT01687569

Brief Summary

The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

1 month

First QC Date

September 14, 2012

Last Update Submit

May 7, 2013

Conditions

Glycaemic Response Measurements

Keywords

Glycaemic Response

Outcome Measures

Primary Outcomes (1)

  • Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC)

    The endpoint will be the blood glucose response curve, calculated from the individual glucose measurements. Evaluated by repeated measures ANOVA on incremental AUC measured in capillary blood.

    120 minutes

Study Arms (3)

Control Cracker

PLACEBO COMPARATOR

Base cracker snack

Other: Control Cracker Snack

Experimental Cracker Snack 1

EXPERIMENTAL

Cracker snack containing test ingredient 1

Other: Experimental Cracker Snack 1

Experimental Cracker Snack 2

EXPERIMENTAL

Cracker snack containing test ingredient 2

Other: Experimental Cracker Snack 2

Interventions

Control Cracker SnackOTHER

Base cracker snack

Control Cracker
Experimental Cracker Snack 1OTHER

Cracker snack containing test ingredient 1

Experimental Cracker Snack 1
Experimental Cracker Snack 2OTHER

Cracker snack containing test ingredient 2

Experimental Cracker Snack 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female (not less than 40% Male)
  • Aged 18 - 55 years
  • Non Smokers
  • Have a body mass index between 18.5 to 29.99 kg/m2
  • Healthy, non-diabetic, no gastric bypass surgery
  • Not allergic to wheat, mustard, dairy, or soy
  • Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
  • Willing and able to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reading Scientific Services Limited (RSSL)

Reading, United Kingdom

Location

Study Officials

  • Rungano Munyuki

    Reading Scientific Services Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 19, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 9, 2013

Record last verified: 2013-05

Locations

GB(1)